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临床试验/NCT06168838
NCT06168838招募中不适用

Anticoagulant-associated Intracranial Hemorrhage: Patient Characteristics and Outcomes From National Institute of Neurology and Neurosurgery Manuel Velasco: Single-Center Observational Study

El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez1 个研究点 分布在 1 个国家目标入组 1,200 人开始时间: 2023年8月9日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,200
试验地点
1
主要终点
Know incidence and prevalence of intracranial bleeding events

研究概览

简要总结

Oral anticoagulant therapy, including factors Xa and 2a inhibitors has become more popular in recent years due to its efficacy and convenience in preventing thrombotic events and reducing the risk for stroke in patients with rosk factors (e.g. atrial fibrillation, deep venous thrombosis, pulmonary embolism). These drugs have replaced traditional therapies such as warfarin, which requires frequent dose adjustments and control blood samples. Warfarin also has a higher risk of bleeding events.

Many patients with atrial fibrillation, particularly old patients and those with comorbidities may have trouble achieving the dose and control requirements for warfarin therapy. On the other hand, Direct Oral Anticoagulant therapies do not require a close monitorization and have a lower risk of bleeding events, which makes them a more attractive option for many patients.

There is solid evidence behind the efficacy and safety of Direct Oral Anticoagulant therapies. Multiple clinical trials have demonstrated that Factor Xa inhibitors like rivaroxaban and apixaban are as effective as warfarin in preventing blood clots and reducing stroke risk in patients living with atrial fibrillation.

These challenges remark the need for new research that can improve our comprehension about the risk of bleeding associated to anticoagulant therapies and develop novel and more effective strategies for minimizing this risk.

Hence, an observational analysis about anticoagulant-associated intracranial hemorrhage may help identifying its incidence and prevalence, as well as treatment patterns and identifying any patient with risk factors linked to these events.

This information can be used to improve patient outcomes and guide future research.

Work Hypothesis: The majority of intracranial hemorrhage events are associated with heparin, low molecular weight heparin and warfarin instead of Factor Xa inhibitors or direct thrombin inhibitors. Nevertheless, the growing use in recent years of factor Xa inhibitors can increase the number of this therapy related bleeding events.

详细描述

Study observational. The total number of subjects for this study will be determined by the number of patients with intracranial bleeding associated with anticoagulant therapy on the clinical records.

Primary objective: To identify the incidence and prevalence of intracranial bleeding events associated to oral anticoagulant therapy including vitamin k antagonists, factor Xa inhibitors and factor 2a inhibitors.

Secondary objective:

  • To identify mortality related to intracranial bleeding associated with oral anticoagulant therapy, including vitamin K antagonists, factor Xa inhibitors and factor 2a inhibitors.
  • To identify patients´ characteristics correlated with intracranial hemorrhage associated with oral anticoagulants.
  • To identify treatment patterns: anticoagulant-associated intracranial bleeding management, including clinical, pharmacological, surgical, and interventional treatments, as well as procoagulant therapies.

Sample size Justification / Statistical Analysis: Non probabilistic, incidental reasoned selection.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Age >18 years
  • Intracranial hemorrhage diagnosis and concomitant oral anticoagulant therapy
  • Available clinical record from January 2015 to July 2023

排除标准

  • Non available clinical record
  • Patients that did not complete follow up on days 30 and 90 after an intracranial bleeding.

结局指标

主要结局

Know incidence and prevalence of intracranial bleeding events

时间窗: From January 2015 to November 2023

To identify the incidence and prevalence of intracranial bleeding events associated to oral anticoagulant therapy including vitamin k antagonists, factor Xa inhibitors and factor 2a inhibitors.

次要结局

未报告次要终点

研究者

发起方
El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
申办方类型
Other
责任方
Principal Investigator
主要研究者

Vanessa Cano

Principal Investigator

El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez

研究点 (1)

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